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The Quality Control Release System

In defining the overall system for Quality Control release of finished products, it is for the manufacturing organisation to decide …

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Good Distribution Practice Guidelines – Some frequently asked questions and their answers

The European Commision has collated a number of frequently asked questions from industry in relation to the¬†new EU¬†guidelines on Good …

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The Rationale for Setting Cleaning Limits in Active Pharmaceutical Ingredient (API) Manufacture

The general rationale behind setting cleaning limits is described below. The contaminant (A) refers to the compound being cleaned, and …

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